Saturday, December 09, 2023 12:18:48 PM
This quarter means (July 1 to September 30th, 2023)
Next quarter (or last) meant (October 1 thru December, 31th 2023)
Next year means (2024)
Submittal of the IDE - (Q211938/S001)
Our next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous FDA comments. And as we near completion we felt it was worth the investment to redo a few studies to ensure that the FDA comments are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter (Q4).
VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).
Animal Therapy Marketing
Marketing to pet parents, clinic owners, veterinarians, and oncologists is complex. Aside from utilizing advertisements in key journals and the social media, the following activities are important:
1. Open new small animal and equine clinics that are reasonably close for pet parents to access.
a. This quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre Equine Clinic in Rochester NH and Hopkinton Animal Hospital in Weare NH.
b. We are currently in contact with several other clinics.
2. Participate in conferences to interface with the animal therapy community.
a. Last Quarter
VSPA Spring Conference in Saint Paul MN
American College of Veterinary Internal Medicine, ACVIM in Philadelphia PA
b. This Quarter
11th International Conference on Isotopes in Saskatoon Canada
Nigel Stevenson from Exubrion Therapeutics® and I presented a joint paper entitled “Precision Radionuclide Therapy for Treating Veterinary Cancerous Tumors and Osteoarthritis.”
Washington State Veterinary Medical Association, WSVMA in Tacoma WA
c. Next Quarter
Veterinary Cancer Society, VCS in Reno NV
American Association of Equine Practitioners, AAEP in San Diego CA
d. Next Year
American College of Veterinary Internal Medicine, ACVIM in Minneapolis MN
American Association of Equine Practitioners, AAEP in Orlando FL.
International Radiation Protection Association (IRPA) and IRPA 16th International Congress and 69th Health Physics Society Annual Meeting in Orlando FL
Dr. Darrell Fisher submitted an abstract: “Direct Interstitial Injection: An Approach to Optimizing Therapeutic Ratios for Safe and Effective Delivery of High-dose Radionuclide Therapy in Treating Solid Tumors”
– Darrell R. Fisher, Versant Medical Physics and Radiation Safety; Michael K. Korenko, Vivos, Inc.
3. Perform animal studies that result in publications in key journals.
a. Next quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol. This will result in two publications.
b. Next year we intend to follow-up with a new small animal study at JHU and an equine study at a university located near “equine territory.”
c. Longer term we will conduct other studies using mice models to support future indications for use, such as lung cancer.
4. Next quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular syndrome. This is a complex syndrome, but if IsoPet is effective, this is a new and large market.
Hope this clears it up.
Know what you own, and know why you own it.
Recent RDGL News
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:40:48 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 12/07/2023 05:15:10 AM
- Form 1-A POS - • Edgar (US Regulatory) • 11/27/2023 10:29:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 04:28:46 PM
- Form 1-A POS - • Edgar (US Regulatory) • 11/03/2023 09:03:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/19/2023 04:18:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 10:33:58 AM
- Form 1-A POS - • Edgar (US Regulatory) • 10/10/2023 04:05:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/04/2023 07:22:21 PM
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